European Carto XP Registry for Validating Specialized CFAE Software - Full Text View

Sponsored by:	Biosense Webster EMEA
Information provided by:	Biosense Webster EMEA
ClinicalTrials.gov Identifier:	NCT00812916

Purpose

The purpose of this prospective observational study (registry) is to determine the acute success rate of a CFAE guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent AF in routine clinical practice.

Condition	Intervention
Atrial Fibrillation	Procedure: RF ablation, using specialized CFAE software

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective Observational Multi-Centre Registry for Validating Specialized CFAE Software in Patients With Persistent or Longstanding Persistent Atrial Fibrillation

Further study details as provided by Biosense Webster EMEA:

Primary Outcome Measures:

The primary efficacy endpoint of this registry is the acute success of the procedure. [ Time Frame: acute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Performance of the CFAE software [ Time Frame: acute ] [ Designated as safety issue: No ]
Procedural time point when the patient rhythm converts into Normal Sinus Rhythm [ Time Frame: acute ] [ Designated as safety issue: No ]
Total CFAE mapping and ablation time [ Time Frame: acute ] [ Designated as safety issue: No ]
Total RF duration [ Time Frame: acute ] [ Designated as safety issue: No ]
Safety: frequency and type of device / procedure related adverse event [ Time Frame: acute ] [ Designated as safety issue: Yes ]
Total fluoroscopy time [ Time Frame: acute ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	210
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
RF ablation RF Ablation using specialized CFAE software	Procedure: RF ablation, using specialized CFAE software RF ablation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with persistent or longstanding persistent AF, needing RF ablation

Criteria

Inclusion Criteria:

persistent or longstanding persistent AF

Exclusion Criteria:

previously underwent RF ablation for AF

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812916

Locations

Belgium
AZ Sint Jan	Recruiting
Brugge, Belgium
Contact: Duytschaever, Prof. +32 050 45 26 70 mattias.duytschaever@azbrugge.be
Denmark
University Hospital Skejby	Recruiting
Aarhus, Denmark
Contact: Jensen, Dr. +45 8 949 62 50 hkjensen@dadlnet.dk
France
Hopital Les Franciscaines	Not yet recruiting
Nimes, France
Contact: Bortone, Dr.
Clinique Pasteur	Not yet recruiting
Toulouse, France
Contact: Albenque, Dr.
CHU Lille	Not yet recruiting
Lille, France
Contact: Lacroix, Dr.
CHU Nantes	Not yet recruiting
Nantes, France
Contact: Landes, Dr.
CHU Arnaud de Villeneuve	Not yet recruiting
Montpellier, France
Contact: Pasquie, Dr.
Hopital Saint Joseph	Not yet recruiting
Marseille, France
Contact: Pisapia, Dr.
Germany
Stadtisches Klinikum Karlsruhe	Not yet recruiting
Karlsruhe, Germany
Contact: Luik, Dr.
Klinik St. Georg	Not yet recruiting
Hamburg, Germany
Contact: Kuck, Prof.
Hungary
GOKI	Recruiting
Budapest, Hungary
Contact: Foldesi, Dr. +36 70 382 0377 folcsa@yahoo.com
Netherlands
Catharina Ziekenhuis	Not yet recruiting
Eindhoven, Netherlands
Contact: Meijer, Dr.
Poland
CSK UM Warsawa	Not yet recruiting
Warszawa, Poland
Contact: Kozluk, Dr.
Spain
Hospital Clinic Barcelona	Not yet recruiting
Barcelona, Spain
Contact: Mont, Dr.

Sponsors and Collaborators

Biosense Webster EMEA

More Information

Responsible Party:	Biosense Webster EMEA ( Ilse Van Keer )
Study ID Numbers:	EXPRESSO
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812916
Health Authority:	Spain: Ethics Committee

Keywords provided by Biosense Webster EMEA:

persistent or longstanding persistent atrial fibrillation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009